Chemistry, Manufacturing, and Controls (CMC) programs are an integral part of the development process which brings a drug from the preclinical phase to the market. Without a CMC program that is properly integrated with the clinical, non-clinical, and marketing programs, the entire development cycle can be delayed, resulting in lost time, revenues and market life cycle. However, the extent of necessary activities in CMC programs can vary depending on the development phase of the drug.
In this audio conference we explore how the skillful combination of drug characterization, manufacturing and packaging processes, analytical test methodology, compliance with applicable regulations and adequate documentation all help to ensure that the CMC portions of an application meet the necessary requirements, as well as supporting the clinical and nonclinical studies being performed to establish the safety and efficacy of the drug.
Optimizing Your Chemistry, Manufacturing & Control Program is being presented by Dr. Miguel de Soto-Perera, Vice President of Pharmaceutical Sciences, with Beckloff Associates, Inc. and airs on Wednesday, June 10, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
